Grade I/II Ankle Sprain
Conditions
Keywords
Ankle sprain, soft tissue injury
Brief summary
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).
Interventions
DRUGdiclofenac diethylamine gel 2.32%
diclofenac diethylamine gel 2.32% twice a day
DRUGPlacebo
Placebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Acute sprain of the lateral ankle, Grade I-II .
Exclusion criteria
1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient. 2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure: Pain on Movement on Day 5 (Change From Baseline). | baseline and day 5 | Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome. |
Countries
Germany
Participant flow
Recruitment details
6 centers in Germany. Recruitment commenced in July 2009 and completed in December 2009.
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day drug | 80 |
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day drug | 80 |
| Placebo. Applied 3 Times a Day. placebo | 82 |
| Total | 242 |
Baseline characteristics
| Characteristic | Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | Placebo. Applied 3 Times a Day. | Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 81 Participants | 80 Participants | 238 Participants |
| Age Continuous | 32.2 years STANDARD_DEVIATION 13.7 | 34.0 years STANDARD_DEVIATION 12.9 | 30.9 years STANDARD_DEVIATION 11.4 | 32.4 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment Germany | 80 participants | 82 participants | 80 participants | 242 participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 31 Participants | 90 Participants |
| Sex: Female, Male Male | 49 Participants | 54 Participants | 49 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 1 / 80 | 1 / 82 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 | 0 / 82 |
Outcome results
Primary
Measure: Pain on Movement on Day 5 (Change From Baseline).
Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.
Time frame: baseline and day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | Measure: Pain on Movement on Day 5 (Change From Baseline). | 49.1 mm | Standard Deviation 19.3 |
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | Measure: Pain on Movement on Day 5 (Change From Baseline). | 49.7 mm | Standard Deviation 21.5 |
| Placebo. Applied 3 Times a Day. | Measure: Pain on Movement on Day 5 (Change From Baseline). | 25.4 mm | Standard Deviation 14.8 |